A Study to Test Whether Different Doses of BI 3000202 Help People With Systemic Lupus Erythematosus (SLE)

Conditions

• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

18 Years - 74 Years

Healthy Volunteers

Not accepted

Interventions

• BI 3000202 — DRUG
  BI 3000202 at different doses
• Placebo — DRUG
  Placebo matching BI 3000202

Study Details

This study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition. Participants are put into 5 groups randomly, which means by chance. 4 groups get different doses of BI 3000202, and 1 group gets a placebo. Placebo tablets look like BI 3000202 tablets but do not contain any medicine. Participants take the tablets for 1 year. All participants also continue their regular treatment for SLE. Participants are in the study for a bit longer than 1 year. During this time, they visit the study site regularly. Doctors check the participants' health and take note of any unwanted effects. They also compare the results between the groups to see if the treatment works.

Key Dates

Start date

Apr 20, 2026

Status verified

Jun 2026

Primary completion

Feb 4, 2029

Completion

Jul 8, 2029

Study Design

Enrollment

405 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: BI 3000202 dose 1
• Experimental: Arm 2: BI 3000202 dose 2
• Experimental: Arm 3: BI 3000202 dose 3
• Experimental: Arm 4: BI 3000202 dose 4
• Placebo Comparator: Arm 5: Placebo

Primary Outcome Measure

Achievement of a Systemic Lupus Erythematosus Responder Index (SRI)-4 response [ Time Frame: At Week 32 ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (31)

Find similar trials in Beverly Hills, CA

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